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NCT Number: NCT03658941

Dural Tenting Sutures in Neurosurgery - is it Necessary?

This study evaluates the necessity of dural tenting sutures in craniotomies. The sutures elevate the dura, a layer between the brain and skull. Supposedly, by doing so, they prevent blood collecting between dura mater and the skull. These blood collections, called epidural hematomas, contributed greatly to postoperative mortality in the early days of neurosurgery. There have been several reports questioning the ongoing need for them in neurosurgery, thanks to modern hemostatic techniques. Moreover, it has been published in the literature, and is a common knowledge as well, that some neurosurgeons do not use these sutures at all, and do not have worse outcomes than their colleagues.

In this study, half of the randomly assigned participants will undergo craniotomy without dural tenting sutures and will be considered an intervention group. The other half will undergo craniotomy with these sutures.

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Key information

Conditions

Epidural Hematoma Hematoma Hematoma, Epidural, Spinal Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, 10th Military Research Hospital and Polyclinic, Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Loading trial locations.

About this study

In the early days of neurosurgery, epidural hemorrhages (EDH) contributed to a high mortality rate after craniotomies. Almost a century ago Walter Dandy reported dural tenting sutures as an effective way of preventing postoperative EDH. Over time, his technique gained in popularity and significance to finally become a neurosurgical standard.

Yet, there have been several retrospective reports questioning the ongoing need for dural tenting sutures. Dandy's explanation that the hemostasis under hypotensive conditions is deceiving and eventually causes EDH may be obsolete. These days, proper intra- and postoperative care, including maintenance of normovolemia and normotension and the use of modern hemostatic agents, may be enough for effective hemostasis. Evading of this suturing technique by some surgeons supports this argument even further.

Thus, there is a fundamental need to evaluate the necessity of dural tenting sutures in an unbiased, evidence-based manner.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female over 18 and under 75 years old
  • qualified for an elective supratentorial craniotomy with a diameter of at least 3 cm
  • Glasgow Coma Scale 15 preoperatively
  • Modified Rankin Scale 0, 1 or 2 preoperatively

Exclusion criteria

  • Coagulation abnormalities before the surgery
  • Revision craniotomy
  • Skull base surgery

Treatment and study plan

No dural tenting techniques

Procedure

Not applying dural tenting sutures during closure of a craniotomy

Other names: tack-up sutures, hitch-up stitches

Dural tenting techniques

Procedure

Applying at least 3 dural tenting sutures during closure of a craniotomy

Other names: tack-up sutures, hitch-up stitches

Primary outcomes

  1. Reoperation due to epidural hematoma

    Time frame: During hospitalization for the surgery, approximately 2 days postoperatively

    Surgery for the postoperative extradural hematoma

Secondary outcomes

  1. Postoperative 30-day mortality

    Time frame: 30-day postoperatively

    The data to measure postoperative 30-day mortality will be obtained from a national database 30 days after the recruitment of all participants has been completed.

  2. Postoperative 30-day readmission to a neurosurgical or neurological department

    Time frame: 30-day postoperatively

    The data required to evaluate readmission rates will be obtained from the hospital databases.

  3. New neurologic deficit or deterioration of a previous one

    Time frame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.

    New neurologic deficit or deterioration of a preoperative deficit, as evaluated on postoperative day 5-7.

  4. Cerebrospinal fluid leak requiring treatment.

    Time frame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.

    Presence of a cerebrospinal fluid leak requiring treatment.

  5. Deterioration of postoperative headaches over 5 Numerical Rating Scale

    Time frame: during hospitalisation, as evaluated 5-7 days postoperatively, or earlier if the patient is discharged before the fifth postsurgical day.

    The Numeric Rating Scale is an 11-point scale for patient self-reporting of pain. It ranges from 0 (no pain) to 10 (the worst imaginable pain). There are no subscales. Higher values indicate more pain and, therefore, represent undesirable outcome.

  6. Epidural collection thickness over 3 mm measured radiographically

    Time frame: During hospitalization, approximately 1-3 days postoperatively

    Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists

  7. Midline shift over 5 mm

    Time frame: During hospitalization, approximately 1-3 days postoperatively

    Extradural collection thickness measured in postoperative Computed Tomography by two independent radiologists

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Prophylactic Use of Dural Tenting Sutures in Elective Craniotomies - is it Necessary? A Multicentre Randomised Study.

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 6, 2018
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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